A new agreement between the WHO and the African Union is expected to strengthen efforts to create the new African Medicines Agency, following the endorsement of the AMA treaty earlier this year.
The World Health Organization and the African Union have signed a memorandum of understanding to formalize their cooperation in three areas, including the ongoing establishment of the future African Medicines Agency that will oversee and coordinate national drug regulatory activities on the continent.
The MoU was signed on 18 November. It also contains new commitments on strengthening disease control and prevention efforts in...
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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be implemented.
The agency also should explain the potential consequences for sponsors if enrollment goals are not met, stakeholders say in comments on the DAP draft guidance. Some commenters urged the FDA to apply waiver criteria flexibly, especially for rare diseases.
The US FDA commissioner also said the hub is looking for an executive director who will work with the CBER and CDER heads, who will serve as co-leads.
Brazil has also published its recent regulatory reliance regulations in English, a move designed to increase confidence in its decisions as it presses on with aligning its national practices with global best practices.
The US FDA commissioner also said the hub is looking for an executive director who will work with the CBER and CDER heads, who will serve as co-leads.
The FDA and sponsors of two new accelerated approval drugs for PBC have taken steps in study design, initiation and reporting transparency to ensure timely completion; Intercept’s COBALT trial of obeticholic acid was negatively impacted by product safety labeling changes and a high crossover rate to commercial drug.
